Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-02-20 @ 3:44 PM
Study NCT ID:
NCT00160459
Status:
COMPLETED
Last Update Posted:
2008-05-29
First Post:
2005-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids
Sponsor:
Abbott
Organization:
Study Overview
Official Title:
A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients With Uterine Leiomyomata.
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.
Detailed Description:
No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the safety and efficacy of asoprisnil 5 mg, 10 mg and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more uterine fibroids, confirmed by ultrasound. Upon completion, subjects at participating sites will be allowed to enter an open-label extension study
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: